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The Future of BioPharma blog provides timely coverage of news that directly impacts the business strategies of the biotech, pharmaceutical and medical device industries. In addition to news coverage, the Future of BioPharma blog features live event coverage from IIR's Biopharmaceutical and Healthcare division.

Wednesday, April 8, 2015

On Wednesday, 1 April 2015, the Biopharmaceutical
Development and Production Week meeting held a Q&A session between
attendees and a selected panel, moderated by Adam Goldstein (Genentech, a
member of the Roche group). Panelists included Nuno Fontes (Boehringer
Ingelheim), David Fritsch (Fritsh Consulting), Francis Kobina Insaidoo, PhD
(Merck Research Laboratories), Chris Antoniou (Biogen Idec), and James D. Vogel
(The BioProcess Institute). The panel first discussed the merits of moving to
an all-single-use facility, such as Amgen’s facility in Singapore as opposed to
continuing to use a stainless-steel-based facility and making modifications with
single-use systems. Questions and discussion focused on the following:

·Does building a complete single-use facility
make sense? The panel agreed that there are some processes (e.g., early stage,
smaller volume, pilot studies) in which the complete or near-complete use of
single-use systems make sense. Larger-volumen(>2,000 L), commercial-scale,
and dedicated processes would be more susceptible for stainless-steel systems.

·How does cost of goods and other economic
factors play a role? The panel agreed that manufacturers must examine all
factors carefully, including timelines for building a facility. Other concepts,
such as ballroom-style or modular facilities also can reduce timelines.

·Are there single-use solutions for high cell
density and high-titer processes? And are there ideas for addressing the
limitations of single-use mixing of such processes? The panel responded that
work on “loop” systems is ongoing through companies such as HyClone/Thermo/GE.

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